Clinical trials: MDS
Very Low Risk, Low Risk, or Intermediate Risk MDS Per IPSS-R
A Study of Etavopivat for the Treatment of Anemia in Patients With Myelodysplastic Syndromes (MDS)
The purpose of this study is to evaluate the safety and efficacy of etavopivat (FT-4202) for the treatment of anemia in adult patients with very low risk, low risk, or intermediate risk MDS.
- Trial name
- NCT05568225
- Testing
- Etavopivat
- Where
- 10 sites in United States, Canada and 2 more
- Volunteers
- 17 people
- Sponsor
- Forma Therapeutics, Inc.
Myelofibrosis, Leukemia, Myelocytic, Acute
A Phase 1/2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Hematologic and Myeloproliferative Malignancies
Phase 1 Part: This was an open-label, sequential dose escalation study of pelabresib (CPI-0610) in patients who had previously been treated for Acute Leukemia, Myelodysplastic/Myeloproliferative Neoplasms.
- Conditions
- Myelofibrosis, Leukemia, Myelocytic, Acute, Myelodysplastic/Myeloproliferative Neoplasm, Myelodysplastic Syndrome (MDS)
- Trial name
- NCT02158858
- Testing
- Pelabresib, Ruxolitinib
- Where
- 48 sites in United States, Belgium and 7 more
- Volunteers
- 336 people
- Sponsor
- Constellation Pharmaceuticals
Hematological Malignancies, Acute Lymphoblastic Leukemia (ALL)
Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS
This study is an open-label, controlled, multicenter, international, Phase III, randomized study of transplantation of NiCord® versus transplantation of one or two unmanipulated, unrelated cord blood units in patients with acute…
- Conditions
- Hematological Malignancies, Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Chronic Myelogenous Leukemia (CML)
- Trial name
- NCT02730299
- Testing
- NiCord® (omidubicel), Cord Blood Unit
- Where
- 52 sites in United States, Brazil and 8 more
- Volunteers
- 125 people
- Sponsor
- Gamida Cell ltd
Myelodysplastic Syndrome (MDS)
STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS
The main objective of this study was to assess the safety profile of MBG453 (sabatolimab) in combination with FDA approved hypomethylating agents (HMAs) of investigator's choice (IV Decitabine or Azacitidine /SC Azacitidine /Oral…
- Trial name
- NCT04878432
- Testing
- MBG453, Azacitidine, Decitabine
- Where
- 15 sites in United States
- Volunteers
- 39 people
- Sponsor
- Novartis Pharmaceuticals
Myelodysplastic Syndrome (MDS)
A Study of Sabatolimab in Combination With Azacitidine and Venetoclax in High or Very High Risk MDS Participants
The purpose of the study was to find out if the new drug sabatolimab when given in combination with azacitidine and venetoclax, was safe and had beneficial effects in participants with high or very high risk myelodysplastic…
- Trial name
- STIMULUS-MDS3 (NCT04812548)
- Testing
- sabatolimab, azacitidine, venetoclax
- Where
- 10 sites in Belgium, France and 5 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
AML, CMML
Study of FF-10501-01 in Patients With Relapsed or Refractory Hematological Malignancies
A Phase 1/2a Dose Escalation Study of FF-10501-01 in Patients with Relapsed or Refractory Hematological Malignancies to determine the safety and tolerability. A total of 6 cohorts will be enrolled in Phase 1 to establish the MTD.
- Conditions
- AML, CMML, MDS
- Trial name
- NCT02193958
- Testing
- FF-10501-01
- Where
- 2 sites in United States
- Volunteers
- 55 people
- Sponsor
- Fujifilm Pharmaceuticals U.S.A., Inc.
MDS
APR-246 & Azacitidine for the Treatment of TP53 Mutant Myelodysplastic Syndromes (MDS)
A Phase III, multicenter, randomized study to compare the rate of complete response (CR) and duration of CR, in patients with TP53-mutated MDS who will receive APR-246 and azacitidine or azacitidine alone.
- Trial name
- NCT03745716
- Testing
- APR-246 + azacitidine, Azacitidine
- Where
- 27 sites in United States, France
- Volunteers
- 154 people
- Sponsor
- Aprea Therapeutics
MDS, Myelodysplastic Syndromes
APR-548 in Combination With Azacitidine for the Treatment of TP53 Myelodysplastic Syndromes (MDS)
Phase 1 study evaluating the safety and efficacy of APR-548 in combination with Azacitidine for the treatment of TP53-Mutant Myelodysplastic Syndromes.
- Trial name
- NCT04638309
- Testing
- APR-548 + Azacitidine
- Where
- 4 sites in United States
- Volunteers
- 4 people
- Sponsor
- Aprea Therapeutics
MDS, CMML
SGI-110 in Participants With Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)
Phase 1-2 dose-escalation randomized study in participants with intermediate or high risk myelodysplastic syndromes (MDS) or acute myelogenous leukemia (AML).
- Conditions
- MDS, CMML, AML
- Trial name
- NCT01261312
- Testing
- Guadecitabine
- Where
- 16 sites in United States, Canada
- Volunteers
- 414 people
- Sponsor
- Astex Pharmaceuticals, Inc.
Myelodysplastic Syndrome, MDS
Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral Cytidine Deaminase Inhibitor (CDAi) in Patients With Myelodysplastic Syndromes (MDS)
This first-in-human, 3-stage, open-label study evaluated the safety and pharmacokinetics of ASTX727, as well as determined the dose for later stages.
- Trial name
- NCT02103478
- Testing
- ASTX727 Dose Escalation, ASTX727 Dose Confirmation, ASTX727 Fixed-Dose Combination
- Where
- 17 sites in United States, Canada
- Volunteers
- 130 people
- Sponsor
- Astex Pharmaceuticals, Inc.
Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts), Anemia
Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden
The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anemia in participants with lower risk MDS and low red blood cell transfusion burden.
- Trial name
- NCT03263091
- Testing
- Roxadustat
- Where
- 124 sites in United States, Australia and 14 more
- Volunteers
- 184 people
- Sponsor
- Kyntra Bio
Myelodysplastic Syndromes (MDS)
A Phase 1b/2 Study of Alvocidib Plus Decitabine or Azacitidine in Patients With MDS
Alvocidib, a cyclin-dependent kinase 9 (CDK 9) inhibitor, in time-sequential therapy demonstrated significant clinical activity in secondary AML patients with prior MDS.
- Trial name
- NCT03593915
- Testing
- Alvocidib Plus Decitabine (during dose escalation only) or Azacitidine
- Where
- 12 sites in United States
- Volunteers
- 20 people
- Sponsor
- Sumitomo Pharma America, Inc.
Multiple Myeloma, Acute Myeloid Leukemia
Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 397 in Subjects With Selected Relapsed or Refractory Hematological Malignancies
Evaluate the safety and tolerability of AMG 397. Estimate the maximum tolerated doses (MTDs) and/or biologically active doses.
- Conditions
- Multiple Myeloma, Acute Myeloid Leukemia, Non-Hodgkins Lymphoma, Myelodysplastic Syndrome
- Trial name
- NCT03465540
- Testing
- AMG 397, Dexamethasone, Azacitidine
- Where
- 21 sites in United States, Australia and 4 more
- Volunteers
- 24 people
- Sponsor
- Amgen
MDS, Myelodysplastic Syndromes
Romiplostim Treatment of Thrombocytopenia in Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
The Data Monitoring Committee (DMC) for study 20060198 recommended that all subjects discontinue treatment of study drug and continue to be followed for long term follow-up. Amgen adopted the DMC recommendation.
- Conditions
- MDS, Myelodysplastic Syndromes, Thrombocytopenia
- Trial name
- NCT00614523
- Testing
- Romiplostim
- Volunteers
- 250 people
- Sponsor
- Amgen
Anemia, Myelodysplastic Syndromes
Study of Sotatercept for the Treatment of Anemia in low-or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) or Non-proliferative Chronic Myelomonocytic Leukemia (CMML)
The primary objective of this study is to determine a safe, tolerable and effective dose of sotatercept that results in the greatest frequency of improvement of anemia in patients diagnosed with low- or intermediate-1 risk…
- Conditions
- Anemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Low to Intermediate-1 MDS
- Trial name
- NCT01736683
- Testing
- Sotatercept
- Where
- 20 sites in United States, France
- Volunteers
- 74 people
- Sponsor
- Merck Sharp & Dohme LLC
AML Including AML de Novo and AML Secondary to MDS, DLBCL
A Dose Exploration Study With Birabresib (MK-8628) in Participants With Selected Hematologic Malignancies (MK-8628-005)
This is a study to determine the recommended dose of birabresib (MK-8628) for further studies in participants with acute myeloid leukemia (AML) including AML de novo and AML secondary to myelodysplastic syndrome (MDS) and in…
- Trial name
- NCT02698189
- Testing
- Birabresib Dose 20 mg
- Volunteers
- 9 people
- Sponsor
- Merck Sharp & Dohme LLC
Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML)
Pilot Study Evaluating Safety & Efficacy of DCBT: NiCord® & UNM CBU to Patients With Hematological Malignancies
Pilot Study Evaluating the Safety and Efficacy of a Co-Transplantation of NiCord®, a UCB-derived ex Vivo Expanded Population of Stem and Progenitor Cells with a Second, Unmanipulated CBU in Patients with Hematological Malignancies
- Conditions
- Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome (MDS), Non-Hodgkin's Lymphoma
- Trial name
- NCT01221857
- Testing
- NiCord®
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Gamida Cell ltd
Hematological Malignancies, Acute Lymphoblastic Leukemia (ALL)
Transplantation of NiCord®, Umbilical Cord Blood-derived Ex Vivo Expanded Cells, in Patients With HM
A Study Evaluating the Safety and Efficacy of Transplantation of a single cord blood unit (CBU) of NiCord®, umbilical cord blood-derived Ex Vivo Expanded Stem and Progenitor Cells in Patients with Hematological Malignancies.
- Conditions
- Hematological Malignancies, Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
- Trial name
- NCT01816230
- Testing
- NiCord®
- Where
- 15 sites in United States, Italy and 3 more
- Volunteers
- 36 people
- Sponsor
- Gamida Cell ltd
Acute Myeloid Leukemia, Leukemia
A Phase I Study of AC220 in Patients With Relapsed/Refractory Acute Myeloid Leukemia Regardless of FLT3 Status
Patients received oral AC220 daily for 14 days to study the side effects, tolerability and best dose for treating relapsed or refractory acute myeloid leukemia, regardless of FLT3 status.
- Conditions
- Acute Myeloid Leukemia, Leukemia, Myelodysplastic Syndrome, AML
- Trial name
- NCT00462761
- Testing
- AC220
- Where
- 5 sites in United States, Georgia
- Volunteers
- 76 people
- Sponsor
- Daiichi Sankyo
MDS, AML
Pharmacokinetics and Safety Study of Azacitidine in Cancer Patients With and Without Impaired Renal Function
The purpose of this study is to evaluate three things. The first being whether azacitidine is absorbed in the body at the same rate or proportion for different concentrations.
- Conditions
- MDS, AML, Solid Tumors, Multiple Myeloma
- Trial name
- RENAL (NCT00652626)
- Testing
- azacitidine
- Where
- 11 sites in United States
- Volunteers
- 31 people
- Sponsor
- Celgene